BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SALTER LABS

    MDR report key: 12447497 · Received September 9, 2021

    Report

    Report Number
    3000219639-2021-00023
    Event Type
    Injury
    Date Received
    September 9, 2021
    Date of Event
    August 12, 2021
    Report Date
    September 9, 2021
    Product Code
    BTR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    IRRITATION/SORES/BURNS CAN BE MANIFESTED BY ITCHING, REDNESS, RASH OR IN EXTREME CASES, OPEN SORES. THE SALTER LABS RESPIRATORY CARE PRODUCTS ARE GENERALLY MADE FROM PLASTIC/PVC, WHICH HAS A GOOD SAFETY PROFILE FOR IRRITATION AND SENSITIVITY. A PLASTIC PRODUCT MAY CAUSE IRRITATION/SORES FOR SEVERAL REASONS, INCLUDING, THE DEVICE HAS BEEN CONTAMINATED WITH AN EXTERNAL SUBSTANCE (E.G., MOLD RELEASE AGENT, LOTIONS, MEDICATIONS) WHICH CAUSE IRRITATION/SORES, USING DEVICE FOR TOO LONG (MAY BECOME ROUGH OR BACTERIALLY CONTAMINATED), OR INDIVIDUAL PATIENT-SPECIFIC HYPERSENSITIVITY. BASED ON THE INFORMATION ABOVE, A REPORT OF IRRITATION/SENSITIVITY/SORES IS NOT REPORTABLE UNLESS A SERIOUS INJURY OR DEATH IS REPORTED IN THE COMPLAINT. AS THIS ISSUE INDICATES THAT BURNS OCCURRED THIS WOULD BE A REPORTABLE EVENT. COMPLAINT HISTORY FOR THIS PART NUMBER WAS REVIEWED FOR THE LAST 24 MONTHS. SIX SIMILAR COMPLAINTS HAVE BEEN REPORTED. BASED ON THE HIGH VOLUME OF SALES, THIS ISSUE DOES NOT APPEAR TO BE TRENDING AT THIS TIME. THIS ISSUE WILL CONTINUE TO BE MONITORED. SOME PATIENTS ARE PARTICULARLY SENSITIVE TO SOME OF THE COMPONENTS OF THE CANNULA, AND CAN DEVELOP AN ALLERGY. THE MOST COMMON SENSITIVITIES ARE TO THE PLASTICIZER, AND ALSO SOMETIMES THE MEK BONDING SOLVENT. LITTLE CAN BE DONE ABOUT THIS, BECAUSE ALL CANNULAS USE SOME TYPE OF PLASTICIZER TO KEEP THE CANNULA SOFT AND FLEXIBLE. THE 16SOFT SERIES OF CANNULAS USE A HIGHER CONCENTRATION OF PLASTICIZER IN THE FACE PIECE, IN ORDER TO MAKE THE TUBING MORE COMFORTABLE. THE PATIENT'S SITUATION MIGHT IMPROVE BY SWITCHING TO THE REGULAR 1600 SERIES CANNULAS, WHICH USE LESS PLASTICIZER. CUSTOMER FOLLOW UP WAS PERFORMED VIA PHONE CALL. RA: THIS FAILURE MODE (R3) SKIN IRRITATION DUE TO EXPOSURE TO A SKIN IRRITANT, IS IDENTIFIED ON THE RISK ANALYSIS FILE (RMA-20017A) FOR OXYGEN CANNULAS. THE SEVERITY OF HARM ASSOCIATED WITH THIS FAILURE MODE IS CONSIDERED AN EXTREME (7) RISK AND DOES NOT MEET THE RISK THRESHOLD FOR CARB REVIEW (8).

    Description of Event or Problem · 0

    CUSTOMER ADVISED CANNULA IS BURNING THE SKIN ON HER FACE. PURCHASED FROM LINCARE.

    Additional Manufacturer Narrative · 1

    IRRITATION/SORES/BURNS CAN BE MANIFESTED BY ITCHING, REDNESS, RASH OR IN EXTREME CASES, OPEN SORES. THE SALTER LABS RESPIRATORY CARE PRODUCTS ARE GENERALLY MADE FROM PLASTIC/PVC, WHICH HAS A GOOD SAFETY PROFILE FOR IRRITATION AND SENSITIVITY. A PLASTIC PRODUCT MAY CAUSE IRRITATION/SORES FOR SEVERAL REASONS, INCLUDING, THE DEVICE HAS BEEN CONTAMINATED WITH AN EXTERNAL SUBSTANCE (E.G., MOLD RELEASE AGENT, LOTIONS, MEDICATIONS) WHICH CAUSE IRRITATION/SORES, USING DEVICE FOR TOO LONG (MAY BECOME ROUGH OR BACTERIALLY CONTAMINATED), OR INDIVIDUAL PATIENT-SPECIFIC HYPERSENSITIVITY. BASED ON THE INFORMATION ABOVE, A REPORT OF IRRITATION/SENSITIVITY/SORES IS NOT REPORTABLE UNLESS A SERIOUS INJURY OR DEATH IS REPORTED IN THE COMPLAINT. AS THIS ISSUE INDICATES THAT BURNS OCCURRED THIS WOULD BE A REPORTABLE EVENT.

    Description of Event or Problem · 1

    CUSTOMER ADVISED CANNULA IS BURNING THE SKIN ON HER FACE. PURCHASED FROM (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1343065 SALTER LABS CANNULA, ADULT, OXYGEN W/3-CHANNEL TUBE 7'(SOFT) BTR 16SOFT-7

    Patients

    Seq Age Sex Outcome Treatment
    1 Other